肝复乐胶囊指纹图谱研究

Study on Fingerprints of Ganfule Capsule

目的建立肝复乐胶囊指纹图谱。方法采用HPLC法建立肝复乐胶囊指纹图谱,并进行方法学验证。绘制10批肝复乐胶囊的HPLC指纹图谱,并与HPLC对照指纹图谱进行相似度评价。结果指纹图谱中有22个共有峰,精密度试验的22个共有峰相对保留时间和相对峰面积RSD均小于2.0;重复性试验的22个共有峰相对保留时间和相对峰面积RSD均小于2.0;稳定性实验的22个共有峰相对保留时间和相对峰面积RSD均小于2.0,说明样品溶液在24h内稳定。10批肝复乐胶囊样品HPLC指纹图谱与HPLC对照指纹图谱相似度均大于0.99。结论该方法准确、重复性好,为肝复乐胶囊内在质量评价提供参考依据。

Objective To establish the fingerprints of Ganfule capsule. Methods The fingerprints of Ganfule capsule was established by HPLC method, and the method was verified. The fingerprints of 10 batches of Ganfule capsule were drawn, and then went through similarity evaluation with the control HPLC fingerprints. Results There are 22 common peaks in the fingerprints. In the precision test, RSD of relative retention time and relative peak area of 22 common peaks are all less than 2.0. In the repeatability test, RSD of relative retention time and relative peak area of 22 common peaks are all less than 2.0. In the stability test, RSD of relative retention time and relative peak area of 22 common peaks are all less than 2.0, which show that the sample solution is stable within 24 h. The similarity of HPLC fingerprints for 10 batches with control HPLC fingerprints were all higher than 0.99. Conclusion The method is accurate and reproducible, and can provide reference for the internal quality evaluation of Ganfule capsule.